Quality Management System (QMS) Plan

An effective quality management system plan is mandatory, especially for companies doing business in regulatory environments, if an organization intends to implement a new quality system or upgrade from their existing paper-based system to an electronic quality management system.

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The Necessity of a Good Quality Management System Plan

As human beings, we have an innate fear of change. Just the same, many organizations are intimidated by the idea of implementing a new quality management system (QMS) or switching from a paper-based QMS to a quality management software solution. If you step back and take a look at the big picture, though, it becomes obvious that only by implementing a proven quality management software solution can a company maximize the efficiency of its quality systems while also ensuring that those systems are compliant, integrated, and cost effective. Automating quality processes also allows regulated companies to attain and maintain regulatory compliance, keep pace with industry trends, and continually make internal improvements. But such massive leaps in improvement don’t just happen with the flip of a switch. Like any major undertaking, they require meticulous planning. So the real question is not “Do I need a quality management system plan?” but “Where do I start?”

A Quality Management System Plan that Works

The following list contains a few key considerations that should be taken into account when developing a quality management system plan:

Establish the top priority: When it comes to quality management, an organization ordinarily has three major priorities: money, time, or process. But if decision makers are unable to determine which priority is number one during planning stages, the variance will inevitably result in serious—and most likely extremely costly—shortcomings in at least one area once the system has been implemented. For instance, if an audit finding has lead to an unavoidable deadline, then time is the organization’s main concern. On the other hand, if internal inefficiencies and broken processes have become so severe that a quality management change is necessary, then the number one priority is process. But if the company knows that the time has come to upgrade to an automated quality management system but funding is limited, then money is the primary concern. Whichever priority may be the most important, it is crucial that it is clearly defined at the very earliest stage in the development of the quality management system plan.

Determine the scope: Establishing the main QMS concerns and the scope of each criterion is the next stage of quality management system plan development. By thoroughly analyzing your organization’s quality system needs and defining quality norms, measurements, and the ultimate direction of the system, you will be better prepared to select the type of electronic quality management system that best fits your organizational requirements.

Review all pertinent open issues: If you want to find the resolution to a problem, you must be able to determine what went wrong and why it went wrong. The same is true when it comes to quality management systems. A refined quality management system plan should include a comprehensive review of all quality requirements, constraints, and procedures in order to narrow the focus to only the most important core issues.

Clarity is the key to good planning: The old saying “Measure twice, but only cut once” also rings true for QMS implementation. Don’t waste time, money, and resources by failing to make double checks and by not clearly establishing your focus and central problems. Let’s take a hypothetical example that occurs all too frequently: A company thinks that the implementation of an expensive QMS software solution with the most cutting edge functionality will fix all their quality problems. Because they thought the new system was a cure-all, they didn’t bother to develop a comprehensive quality management system plan that identified their main problem which actually wasn’t the quality management system itself—it was the broken quality processes that were being fed into the system. Consequently, the costly new QMS didn’t resolve all the company’s problems; it simply incorporated bad quality processes into a new system, thereby creating additional problems.

Leverage internal and external resources: Outside experts, if available, can provide a wealth of knowledge and experience when devising a quality management system plan. But don’t discount the value of internal subject matter experts (SMEs) who most likely have a better handle on what the organization’s needs are and what the organization expects from its new QMS.

Take advantage of team decision making: When a team comprised of personnel from every department unites to add their collective input into a cohesive quality management system plan, the investment in a new system is much easier to justify and will ensure that all essential bases are covered.

Don’t force broken processes into a new and improved system: The primary purpose of implementing a new QMS is to fix and enhance quality processes, so beware of the temptation to force the inefficient processes currently in practice into a functional electronic system. Rather, focus on adjusting old defective processes and improving them to fit the new software system.

These are just a few considerations to take into account when developing a quality management system plan. In addition to the information presented above, however, one must always focus on the main goals of a QMS: improving product quality and accelerating time to market. Plus, remember that every organization has its own specialized requirements and desires, so additional planning goals and expectations need to be determined in order to create a comprehensive quality management system plan that best suits your organization. If the company takes the time and effort to develop an effective and thorough quality management system plan prior to implementation, it will be able to manufacture many more products of a higher standard of quality at a significantly lower cost.

To learn more about MasterControl’s Quality management software system plan, contact a MasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.